We are seeking a highly skilled and motivated Senior QC Officer – Microbiology to join our Quality Control team at Dammam Plant. The successful candidate will be responsible for conducting and overseeing microbiological testing to ensure product quality, compliance with regulatory standards, and continuous improvement in laboratory practices.
Key Responsibilities
- Routine and non‑routine microbiological testing according to Standard Operating Procedures (SOPs) to ensure product quality and compliance
- Compile and analyze data, identify anomalies, and generate high‑quality, accurate reports to support production and characterization studies
- Ensure all laboratory work is performed in accordance with cGMP (current Good Manufacturing Practices) and safety assessments
- Conduct formal analytical validation programs and support extended method qualification
- Work with cross‑functional teams, influence team members, and support audits concerning departmental data and processes
- Occasionally mentor junior analysts and apprentices
- Conduct regular environmental monitoring of cleanrooms and other controlled areas to ensure compliance with microbiological standards
- Manage the collection, handling, and storage of samples, ensuring proper documentation and traceability
- Lead investigations into microbiological deviations and out‑of‑specification results, identifying root causes and implementing corrective actions
- Ensure all microbiological testing equipment is properly calibrated and maintained
- Develop and deliver training programs for laboratory staff on microbiological techniques and safety protocol
- Maintain accurate and detailed records of all testing procedures, results, and equipment maintenance
- Stay updated with changes in regulatory requirements and ensure laboratory practices are compliant
- Prepare for and participate in internal and external audits, providing necessary documentation and explanations
- Perform sterility testing on pharmaceutical products to ensure they are free from microbial contamination
- Conduct bioburden testing to determine the number of viable microorganisms in raw materials, in‑process samples, and finished products
- Carry out endotoxin testing to detect bacterial endotoxins in products, ensuring they meet safety standards
- Prepare and validate microbiological media used for testing, ensuring consistency and reliability
- Analyze trends in microbiological data to identify potential issues and areas for improvement
- Conduct risk assessments related to microbiological testing and implement mitigation strategies
- Participate in continuous improvement initiatives to enhance laboratory processes and efficiency
- Ensure Annex 1 compliance in different production areas in addition to Sterility assurance mindset & coaching
- Have the capabilities to be sterility assurance SME with high level knowledge to CCS